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临床试验/NCT06261437
NCT06261437已完成不适用

Effect of Ration Formulations on Warfighter Energy Balance and Physical Performance During a Field Training Exercise

United States Army Research Institute of Environmental Medicine2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年2月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Energy intake

研究概览

简要总结

The goal of this randomized clinical trial is to determine the effects of consuming the Close Combat Assault Ration (CCAR) compared to the First Strike Ration (FSR) during a 7-day strenuous military training on energy intake and energy balance in healthy, Active Duty Warfighters.

The main questions it aims to answer are:

  • Will consuming the CCAR result in lower energy intake or energy balance compared to consumption of the FSR?
  • Will consuming the CCAR result in lower lower body strength or anaerobic power compared to consuming the FSR?
  • Will those consuming the CCAR report lower ration acceptability or greater gastrointestinal side effects compared to those consuming the FSR?

Participants will be asked to consume either the CCAR or FSR as the sole nutrition source during a 7-day field training exercise (FTX). The vertical jump test, running-based anaerobic sprint test, and lower-body strength pull will be conducted pre and post the 7-day FTX to assess physical performance. Energy expenditure and intake will be measured by the doubly-labelled water method and dietary logs, respectively. Surveys will be completed to assess ration acceptability and gastrointestinal symptoms.

Researchers will compare the CCAR and FSR groups to see if their consumption impacted energy intake, energy balance, physical performance, ration acceptance, or gastrointestinal side effects.

详细描述

Army modernization priorities have identified the need to build the "capability to sustain multiple Brigade Combat Teams for up to seven days without periodic resupply to support semi-independent operations". To address this challenge and meet modernization requirements, ration developers from the Combat Feeding Division (CFD), Soldier Sustainment Directorate, Combat Capabilities Development Command - Soldier Center (DEVCOM-SC) developed the next generation ration, the Close Combat Assault Ration (CCAR). The CCAR is produced using novel food processing techniques that reduce weight and volume by removing air and water and increase the energy density by increasing the relative fat content. The result is a lightweight, low volume, energy-dense, shelf-stable, daily combat assault ration that provides Warfighters with meals that can be consumed while on the move, requiring no heating and little to no field preparation.

The ration will provide approximately 2800 kcals/day (47% carbohydrate, 12% protein, 41% fat) and includes a greater distribution of energy from fat to enable a smaller logistic footprint than the First Strike Ration (FSR, 2800 kcals/d; 58% carbohydrate, 12% protein, 30% fat).

This proposed project will evaluate the CCAR relative to the current recommended materiel solution (i.e., the FSR) in a field setting that approximates the operational conditions under which the ration will be consumed. Specifically, the proposed effort will compare energy intake, energy balance, physical performance, appetite, ration acceptability, and gastrointestinal responses in military personnel randomized to consume the CCAR or FSR in a multi-day training environment.

Participants will be randomized to consume the CCAR or FSR during a 7-day field training exercise. Physical performance will be assessed PRE and POST by the Running-Based Anaerobic Sprint Test, lower-body strength pull, and vertical jump. A subset of participants will consume doubly-labeled water and provide urine samples throughout the study period to measure energy expenditure. Appetite, ration acceptability, and gastrointestinal symptoms will be assessed by daily surveys. Energy intake will be measured by review of uneaten ration products and daily logs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • Active-duty male or female military personnel who are actively participating in the 7-day strenuous military training exercise.
  • Willing to consume only foods/beverages provided by study staff during the training exercise, except for coffee and water.

排除标准

  • Any injury or health condition limiting full participation in the 7-day Field Training Exercise.
  • Any food allergy, lactose intolerance, or vegetarian practices.
  • Not willing to participate in all study procedures.

结局指标

主要结局

Energy intake

时间窗: From study day 1 through 7

Energy intake will be measured with daily food records and a review of food waste.

Energy expenditure

时间窗: From baseline to study day 7

Energy expenditure will be measured using the doubly-labeled water method.

Energy balance

时间窗: From baseline to study day 7.

Energy balance will measure the difference between energy intake and expenditure.

次要结局

  • Physical performance (vertical jump)(At baseline (PRE) and POST the 7-day FTX (i.e., study day 8))
  • Physical performance (peak power)(At baseline (PRE) and POST the 7-day FTX (i.e., study day 8))
  • Physical performance (Anaerobic capacity)(At baseline (PRE) and POST the 7-day FTX (i.e., study day 8))
  • Gastrointestinal Quality of Life Index(From baseline to study day 8)
  • Physical performance (lower-body strength)(At baseline (PRE) and POST the 7-day FTX (i.e., study day 8))
  • Food acceptance scale(From study day 1 through 7)
  • Hunger and Satiety Visual Analog Scales(From baseline to study day 8)

研究者

发起方
United States Army Research Institute of Environmental Medicine
申办方类型
Fed
责任方
Sponsor

研究点 (2)

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